- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02724891
Web-based Validation Pelvic Floor Questionnaires
Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Health questionnaires and health diaries are two forms of patient-reported outcomes (PRO) commonly used in healthcare. Health questionnaires are often used as intake logs, discerning and recording the symptoms and severity of a problem at the time of presentation. Health diaries, in contrast, are ongoing logs which allow for mindful attention to symptoms and monitoring of response to therapy. Unfortunately, both types of PRO forms are often under-utilized or uninterpretable because they are collected on paper. Within urogynecology, PRO scales such as the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Bristol Stool Chart, Bladder Diaries and others are used ubiquitously. Their impact, however, is diminished by poor compliance and recall bias. The move towards electronic PRO measures would be endorsed by patients (who can track and interact with their data), physicians (who can track progress and study group outcomes) and by regulators (who want to ensure accurate and reproducible data collection). Electronic PRO tools, particularly on the patient's own device, would allow for increased rate of reporting through mobile availability, time stamping of data to prevent recall bias and reduction in data entry mistakes and costs.
Study Procedures After informed consent is obtained, demographic data will be collected. Subjects will be administered the questionnaires either in paper or web-based or smartphone form based on a random number block scheme. At least two weeks later but prior to treatment they will complete the other form of the questionnaire. This can occur at their next office visit or can be completed at home. Subjects will be emailed and/or called by research staff to remind them to complete the second set of questionnaires.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 1N4
- University of Calgary
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, Spojené státy, 72701
- University of Arkansas
-
-
New York
-
New York, New York, Spojené státy, 10032
- Columbia University Irving Medical Center
-
-
Texas
-
Houston, Texas, Spojené státy, 77030
- Houston Methodist Hospital
-
-
Wisconsin
-
Madison, Wisconsin, Spojené státy, 53726
- University of Wisconsin School of Medicine and Public Health
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
This is a prospective validation study. Subjects will be recruited at their visit to the Female Pelvic Medicine and Reconstructive Surgery offices and clinics at Columbia and Cornell. Demographic information will be collected at the initial visit/enrollment including age, race, parity, and presenting complaint.
Questionnaires will be administered based on a randomization scheme. These include:
- Pelvic Floor Disorders Inventory short form (PFDI-20)
- Pelvic Floor Impact Questionnaire (PFIQ-7)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
- Bristol Stool Scale (BSS)
Questionnaires will be administered via paper-based form, web-based, or smartphone app based on randomization scheme.
Popis
Inclusion Criteria:
- Women at least 18 years of age presenting with pelvic floor dysfunction
Exclusion Criteria:
- Unable to repeat questionnaires or return to the office in 2 weeks
- No access to computer/web or smartphone
- Pregnancy (as gestational age will advance during 2 week time interval and symptoms may change)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Crossover
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Arm 1 paper form first
paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
|
questionnaires in paper form
questionnaires in web/smartphone
|
Arm 2 web/smartphone form first
web/smart phone questionnaires first then paper questionnaires after a 2-week washout period
|
questionnaires in paper form
questionnaires in web/smartphone
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Test-retest reliability of PFDI-20 in the electronic format
Časové okno: minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PFDI-20 with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Test-retest reliability of PFIQ-7 in the electronic format
Časové okno: minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PFIQ-7 with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Test-retest reliability of PISQ-12 in the electronic format
Časové okno: minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PISQ-12 with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Test-retest reliability of BSS in the electronic format
Časové okno: minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the BSS with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Cara Grimes, MD, Columbia University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- AAAO8451
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Dysfunkce pánevního dna
-
Hams Hamed AbdelrahmanDokončeno
-
Khon Kaen UniversityNeznámýChronická frontální rinosinusitida | Vertex to Floor PositionThajsko
Klinické studie na paper form
-
Manchester University NHS Foundation TrustUniversity of ManchesterDokončeno
-
University of Campinas, BrazilZatím nenabíráme
-
University of Southern DenmarkEsbjerg Municipality; Municipality of Slagelse; Municipality of Odense; Christian... a další spolupracovníciDokončeno
-
Radicle ScienceAktivní, ne náborBolest břicha | Trávení | Poruchy GISpojené státy
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)DokončenoFyzická aktivita | Parkinsonova choroba | Zůstatek | Padající | KineziofobieKrocan
-
Afyonkarahisar Health Sciences UniversityAktivní, ne nábor
-
Goztepe Training and Research HospitalDokončenoCukrovka typu 2 | Variabilita srdeční frekvenceKrocan
-
Konya Beyhekim Training and Research HospitalNábor
-
Inonu UniversityNeznámýÚzkostné poruchy | MelatoninKrocan
-
Radicle ScienceAktivní, ne náborBolest břicha | Trávení | Poruchy GISpojené státy